Qualifications

• Medical-device industry experience is mandatory
• Experience managing CAPA and nonconformance
• Proficiency in quality investigations and root cause analysis
• Strong knowledge of Quality Management Systems
• Familiarity with ISO 13485 standards
• Understanding of FDA QMSR / 21 CFR Part 820 regulations
• Experience in continuous improvement and process enhancements
• Knowledge of Lean Manufacturing and Six Sigma methodologies
• Background in highly regulated manufacturing environments

Responsibilities

• Manage and investigate nonconforming materials, products, and processes
• Support the complete CAPA lifecycle, including all documentation
• Conduct structured Root Cause Analysis (RCA) and problem-solving techniques
• Maintain compliance with Quality Management System requirements
• Ensure adherence to ISO 13485 and FDA 21 CFR Part 820/QMSR
• Identify and implement quality and manufacturing process improvements
• Apply Lean Manufacturing and Six Sigma principles to enhance operational performance
• Support preparation of inspection-ready documentation and quality records
• Collaborate with manufacturing and engineering teams to resolve quality issues

Benefits

• Work within a regulated environment that fosters compliance
• Opportunity to implement and influence quality improvements
• Collaboration across cross-functional teams to enhance skillsets
• Engagement with continuous improvement practices for career development
• Experience with both Lean and Six Sigma methodologies to advance operational efficiency